Study of the Safety and Tolerability of the Broad-spectrum Probiotic Medicine "AS-Probionorm"

NCT06252831 | Completed Phase 1

• 1 other identifier: ПМ-001-23г
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The subject of this clinical trial is the medicine "AS-Probionorm". Pharmacological group - Antidiarrheal drugs. Antidiarrheal microorganisms. Microorganisms that produce lactic acid. The investigational probiotic medicine "AS-Probionorm" was created on the basis of an association of lactic acid bacteria with targeted action for oral use for the treatment of inflammatory and infectious diseases of the human gastrointestinal tract. The first phase of a clinical trial is the first test of a medicine conducted on healthy volunteers to establish tolerability and safety. According to the goal and objectives of the phase I clinical trial, the main parameter is to study the safety and tolerability of the medicine throughout the entire study period. Phase I of the clinical trial of the medicine included 20 healthy subjects of both sexes aged 18-50 years. Clinical and laboratory parameters to characterize the safety of the medicine: medical history, physical examination, ECG, general and biochemical blood tests, urine and stool tests. Selection and Exclusion of Subjects: Prior to inclusion in a clinical trial, each trial subject must first sign an Informed Consent Form for Participation in the Study, followed by a screening examination of each subject, including a variety of procedures, medical history, and physical examination. Each subject participating in the survey will be assigned an identification number. Study design: open-label, single-center, phase I of clinical trial. Dosage regimen - 1 sachet (1 g) 2 times a day with an interval of 12 hours. The total duration of study subjects' participation in the study is 21 days. Tolerability of the study drug: Tolerability of the drug will be assessed based on subjective symptoms and sensations reported by patients and objective data obtained by the investigator during the study. The frequency of occurrence and nature of adverse reactions are also taken into account. The degree of tolerability of the study drug will be determined in three gradations: intolerance, absence of undesirable drug reactions (side reactions), undesirable drug reactions (side effects) not classified as serious. Ethical and Legal Issues in Clinical Research: This clinical trial will be conducted in accordance with the principles set forth by the 18th World Medical Assembly (Helsinki, 1964) and the ICH guidelines for good clinical practice (GCP), and in accordance with all international and national laws and regulations.

Conditions

Intestinal Infections; Dysbacteriosis

Keywords

probiotic; intestinal infections; dysbiosis; lactic acid bacteria; phase 1 of clinical trial

Outcome Measures

Primary Outcomes (2)

• Safety assessment criteria

  Absence of clinically significant changes in the parameters of general blood and urine tests, biochemical blood tests, and microbiological studies of stool of the study subjects during the study period.

  21 days

• Tolerability of the study drug

  The degree of tolerability of the study drug will be determined in three gradations: * Intolerance - the appearance of local signs of allergy/pseudoallergy and systemic signs - tachycardia (heart rate more than 90 per minute within 30 minutes after administration), decreased blood pressure (less than 100/60 mmHg within 30 minutes after application), serious adverse drug reactions. * Absence of unwanted drug reactions (side reactions). * Adverse drug reactions (side effects) that are not classified as serious.

  21 days

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

1 sachet (1 g) take 2 times a day with an interval of 12 hours. The duration of taking the medicine is 7 days. The study is carried out on an outpatient basis. The total duration of each subject's participation in the clinical trial is no more than 21±1 days.

Drug: "AS-Probionorm"

Interventions

"AS-Probionorm" DRUG

Dosage form - powder for the preparation of a solution for oral administration. Dosage regimen -1 sachet (1 g) take 2 times a day with an interval of 12 hours. Apply 15-20 minutes before meals in the morning and evening. Before use, the medicine is mixed with 30-50 ml of boiled water at room temperature, resulting in a cream-colored suspension. The resulting aqueous suspension should be drunk without achieving complete dissolution. The diluted drug cannot be stored. The duration of taking the medicine is 7 days. The study is carried out on an outpatient basis. The total duration of each subject's participation in the clinical trial is no more than 21 ± 1 days. Throughout the entire study period, the research subject has the opportunity to contact the research team on all questions relating to the nature of this study. After completion of the entire observation period of 21 days, there is no follow-up of study subjects under the trial protocol.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers of both sexes aged 18-50 years with a verified state of health, absence of chronic and acute systemic and intestinal diseases; for women - a negative pregnancy test and agreement to adhere to adequate methods of contraception.
• Voluntary desire to participate in the study.

You may not qualify if:

• Persons with a history of allergies to milk, and during screening (drug, pollen and other types), individual hypersensitivity to the components of the drug;
• Persons with chronic diseases (tuberculosis, hepatitis, HIV infection, diabetes mellitus, cancer, blood diseases), chronic renal failure, chronic liver failure, exacerbations of chronic diseases;
• Persons taking parallel participation in clinical trials of other drugs or participating in them for 3 months from the start of the current study;
• Persons planning to participate in studies should not take any other medications for 2 weeks before clinical studies of the test drug;
• Persons from the category of "vulnerable patients" (homeless, military personnel, incapacitated, patients in emergency conditions, other persons who may be under pressure);
• Pregnancy and breastfeeding;
• The research subject does not agree to perform the procedures required by the protocol and is unable to adhere to the procedure schedule.

Sponsors & Collaborators

• Industrial Microbiology LLP: lead

Study Sites (1)

MIPO Clinic LLP

Almaty, Kazakhstan

Location

Related Publications (3)

• A.K. Sadanov, N.N. Gavrilova, I.A. Ratnikova, S.E. Orazymbet, E.Zh. Shorabayev, Zh.T. Musabekov, R.Zh. Kaptagay, L.E. Protasyuk, L.A. Kosheleva, S.B. Dzhailyauova Association of bacteria for the production of a medicinal probiotic preparation with a wide spectrum of antimicrobial action // Microbiology and virology. - ISSN 2304-585X. - No. 1 (40) 2023. -- pp. 116-126. - doi: 10.53729/MV-AS.2023.01.07; IF-0.038.

  BACKGROUND

• Sadanov A.K., Gavrilova N.N., Ratnikova I.A., Orazymbet S.E., Shorabayev E.Zh., Protasyuk L.E. Antimicrobial activity of the therapeutic and prophylactic probiotic drug "AS-Probionorm" // Proc. on Sat. mater. Intl. scientific-practical conf. "Biotechnology and biological safety: achievements and development prospects", dedicated to the 65th anniversary of the Research Institute for Biological Safety Problems. - Almaty. - September 6-8, 2023 - P. 134. - UDC 57/60 BBK 28/30.16 B63. ISBN 978-601-305-533-6.

  BACKGROUND

• A.K. Sadanov, N.N. Gavrilova, I.A. Ratnikova, S.E. Orazymbet, L.E. Protasiuk, A.D. Massirbaeva Technology for the production of Lyophilizate of an association of Lactic acid bacteria included in the Medicinal product AS-Probionorm // Research J. Pharm. and Tech. 16(11):5334-5340. - November 2023. - DOI: 10.52711/0974-360X.2023.00864. - ISSN 0974-3618 (Print), 0974-360X (Online). Q2, 56th percentile.

  BACKGROUND

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ilyas Kulmagambetov, Doctor of Med. Sc.

  Centre for Clinical Medicine and Research LLP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Objectives of the study: Determine the safety and tolerability of the study medicine "AS-Probionorm" (powder 1 g in a sachet) in healthy study subjects. The study included the following stages: Stage 1 of the study (introductory stage) included recruitment and screening of healthy volunteers - study participants, signing of informed consent, medical examination and laboratory tests. Stage 2 of the study (baseline control stage) included clinical measurements before the start of the study (baseline measurements) on each subject to obtain baseline data, which were then compared with the results after the end of the study. Stage 3 of the study (the stage of dynamic observation of the treatment effect and safety monitoring after the study) included clinical observations in each subject daily during the use of the study medicine and a week after the last use (21 days in total).

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 12, 2024
• Study Start: September 2, 2023
• Primary Completion: October 14, 2023
• Study Completion: October 14, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)